Drug-coated Balloon Angioplasty Research Articles

Long-Term Clinical Outcomes of Drug-Coated Balloon Following Directional Coronary Atherectomy for Bifurcated or Ostial Lesions in the DCA/DCB Registry.

The long-term efficacy of drug-coated balloon (DCB) angioplasty for large bifurcation lesions, particularly those involving the left main trunk (LMT), remains unclear. This study aimed to evaluate the long-term outcomes of directional coronary atherectomy followed by DCB (DCA/DCB) for large bifurcation lesions. This retrospective multicenter study analyzed 129 cases from the DCA/DCB registry, with 80.4% involving LMT bifurcation lesions. Building on previously reported 12-month outcomes, this study assessed long-term results. The primary endpoint was clinically driven (CD) target lesion revascularization (TLR) at 36 months. Secondary endpoints included CD target vessel revascularization (TVR); CD target vessel failure (TVF); and adverse events, such as all-cause mortality, cardiac death, target vessel acute myocardial infarction (AMI), and the need for coronary artery bypass grafting (CABG), at 24 and 36 months. The mean follow-up was 53.4 ± 23.9 months. The CD-TLR rate was 5.0% at 24 months, and the primary endpoint was 5.9% at 36 months. CD-TVR rates were 14.0% at 24 months and 15.0% at 36 months, while CD-TVF rates were 14.9% at 24 months and 16.7% at 36 months. Adverse events included all-cause mortality rates of 0.8% at 24 months and 1.8% at 36 months, and cardiac death rates of 0.8% at both 24 and 36 months. No target vessel AMI or CABG procedures were reported. The consistently low CD-TLR rate at 36 months supports the efficacy of the DCA/DCB strategy for large bifurcation lesions, including LMT, indicating its sustained effectiveness. These findings highlight the viability of this treatment approach.

Comparative outcomes of drug-coated balloon angioplasty versus second-generation drug-eluting stent for in-stent restenosis: a real-world data analysis

Abstract Background Coronary in-stent restenosis (ISR) poses a significant challenge in interventional cardiology, with optimal treatment strategies being the subject of ongoing debate. Current clinical guidelines offer a choice between drug-coated balloon angioplasty (DCB) and repeat stenting with second-generation drug-eluting stents (DES), each with distinct implications for long-term patient outcomes. Purpose The aim of this study is to compare 1-year outcomes between DCB angioplasty and second-generation DES in the treatment of ISR. Longitudinal real-world data are used from the OBSERVABLE database, which comprises German health claims data between 2012 and 2021. Methods A total of 10,440 ISR individuals undergoing DCB or DES intervention were identified. After exclusion of bare-metal stents, first generation stents and non-DCBs, 3,810 propensity score-matched individuals remained. The primary outcome was the composite of all-cause mortality and myocardial infraction (MI). Secondary outcomes included all-cause death, MI, and bleeding as a safety outcome. Results At 1-year follow-up, the primary outcome of all-cause mortality and MI was observed in 246 individuals (12.9%) in the DES group, compared with 201 individuals (10.6%) in the DCB group (HR, 1.27; 95% CI, 1.06-1.53). Sensitivity analysis confirmed the robustness of these findings. Secondary outcomes revealed higher all-cause mortality in the DES group (7.9%) compared to the DCB group (6.3%) (HR, 1.31; 95% CI, 1.03-1.66), with no difference in MI. Bleeding events were comparable between the two treatments, with 244 individuals (12.8%) in the DES group and 206 individuals (10.8%) in the DCB group (HR, 1.17; 95% CI, 0.89-1.53). Conclusion This real-world data analysis demonstrated a higher incidence of the primary composite endpoint of all-cause mortality and MI within one year, after treatment with DES compared to DCB. Our results support prior findings about the safety profile of repeated DES implantation and strengthen DCB as a potential superior alternative to DES in ISR management.

Provisional stenting : drug-coated versus uncoated balloon for side branch in coronary bifurcation lesions: randomized study

Abstract Introduction The rePOT technique is a novel and easily applied approach for coronary bifurcations. Drug-Coated Balloon (DCB) angioplasty is increasingly being utilized in management of small vessels and coronary bifurcation lesions. Herein, we propose a new approach for treating coronary bifurcation lesions with the application of DCB to treat the side-branch in addition to the rePOT technique: the POT-sideDCB-POT technique. Materiel and Method: We described for the first time the POT-sideDCB-POT method for true bifurcation lesions (including the side-branch ostium), which is in line with the recommended management algorithm of the European Bifurcation Club8 consisting of a sequential approach to bifurcation stenting using the provisional strategy. The POT-sideDCB-POT is easy to perform and respects the geometry of all the three bifurcation segments. Results Overall, 100 patients with CBLs treated with provisional stenting using DES were included from our studie,50 with DCB side branche and 50 with UCB With a follow-up duration of 12 months, SB protection with DCB was associated with a lower degree of postoperative diameter stenosis (mean difference (MD): −10.35%, 95% confidence interval (CI): −13.17 to−8.53, p < 0.001; I2 = 0%) and less late lumen loss (MD: −0.18 mm, 95% CI:−0.28 to−0.10, p < 0.001; I2 = 69%) of SB compared to those with UCB. Moreover, SB protection with DCB was associated with reduced risks of target lesion revascularization (risk ratio [RR]: 0.45, 95% CI: 0.27 to 0.88, p = 0.02; I2 = 0%) and major adverse cardiovascular events (RR: 0.42, 95% CI: 0.27 to 0.66, p < 0.01; I2 = 0%). Subgroup analysis according to the study design showed similar results. Conclusions For patients with CBL treated with provisional stenting using DES, SB protection with DCB was associated with better angiographic and clinical outcomes than those with UCB.

Impact of the lower extremity arterial calcification score on clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease

Abstract Background Severe calcification, assessed using the peripheral artery calcification scoring system (PACCS), is associated with poor clinical outcomes after endovascular treatment (EVT) for de novo femoropopliteal lesions. However, the PACCS classification is a qualitative assessment performed in the angiographic room, and there are no established indicators for the quantitative assessment of calcification prior to treatment. Purpose We aimed to investigate the impact of the lower extremity arterial calcification score (LEACS) calculated using non-contrast lower limb computed tomography on clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease. Methods We retrospectively analyzed the clinical outcomes of 141 consecutive patients treated at our center for de novo femoropopliteal artery disease using a drug-coated balloon between April 2018 and December 2022. Patients who did not undergo lower limb computed tomography before EVT were excluded from the analyses. LEACS was determined based on the method used to calculate the Agatston score for the coronary arteries. Each patient’s score consisted of a sum of calcification scores from ostium of superficial artery to the popliteal artery at the knee joint of treated limb. The primary and secondary outcomes measured were primary patency and clinically-driven target vessel revascularization (CD-TVR) at 1 year. Cox proportional hazards analysis was used to explore independent predictors of clinical outcomes. The study population was divided into higher and lower LEACS groups based on the cut-off value (1750), which best discriminated patency, and the outcomes were compared between the two groups. Results In the higher and lower LEACS groups, the mean age was 75.1 ± 9.1 years and 75.5 ± 11.0 years (p = 0.87) and the mean lesion length was 170.3±102.8 mm and 157.7±112.1 mm (p = 0.64), respectively. The higher LEACS group showed significantly lower 1-year patency than the lower LEACS group (53.5% vs. 84.3%, log-rank, p = 0.041). In addition, freedom from 1-year CD-TVR was significantly lower in the higher LEACS group than in the lower LEACS group (66.8% vs. 93.7%, p = 0.047). The Cox proportional hazard analysis showed that the higher LEACS group was an independent predictor of 1-year restenosis (odds ratio: 2.80, 95% confidence interval: 1.24–8.84, p=0.037), along with a small (< 5 mm) reference vessel diameter (odds ratio: 3.55, 95% confidence interval: 1.44–9.53, p=0.028). Conclusion Higher LEACS scores were independently associated with clinical outcomes after drug-coated balloon angioplasty for de novo femoropopliteal artery disease. Non-contrast lower limb computed tomography is an acceptable and feasible option for predicting the outcomes in patients with de novo femoropopliteal artery disease prior to treatment.

Atherectomy Followed by Drug-Coated Balloon Angioplasty Versus Surgery for Symptomatic Deep Femoral Artery Arteriosclerotic Disease.

Limited data are available regarding endovascular therapy of arteriosclerotic lesions of the deep femoral artery (DFA). In this study, we compare the outcomes of atherectomy combined with drug-coated balloon (DCB) angioplasty and open repair of DFA lesions. This is a multicenter retrospective registry of patients with peripheral artery occlusive disease Rutherford categories 2 to 5 treated by surgical profundaplasty (SP) or atherectomy followed by DCB for DFA lesions (symptomatic DFA). The primary endpoint was clinically driven target lesion revascularization (CD-TLR). Overall mortality, target limb reinterventions, major amputation, and major adverse limb events (MALEs) were additionally analyzed. A total of 373 patients treated for an arteriosclerotic lesion of the DFA between February 2015 and August 2021 were included, 301 treated by SP and 72 with atherectomy and DCB. The rates of chronic limb threatening ischemia (CLTI) were 42.2% and 22.2% (p<0.002) for the surgical and endovascular groups, respectively. A previous DFA intervention was more frequent in the endovascular group (30.6% vs 15.3%; p<0.003). Patients who had an open repair were more likely to have an occlusion of the profunda (34.9% vs 19.7%, p=0.014), severe calcified lesions (26.5% vs 5.6%, p=0.001), and lesions longer than 20 mm (95.7% vs 88.7%, p=0.024). After propensity score matching, no significant differences were found with regard to technical and hemodynamic success. At 24 months, no difference was found in terms of freedom from CD-TLR (95.7% vs 96.8%), freedom from all-cause mortality (94.2% vs 98.5%), freedom from MALE (90.4% vs 93.9%), and amputation-free survival (93.8% vs 97%). Following endovascular therapy, length of stay was significantly lower (p<0.001) and any reintervention on the index limb was more frequent (p=0.039). Patients with CLTI, occlusion of profunda, severe calcified lesions, and longer lesions are more frequently treated by open surgery, while reinterventions are more commonly treated by atherectomy and DCB. In patients with comparable clinical and lesion characteristics after matching, endovascular and surgical reconstruction of DFA lesions showed similar mid-term clinical outcomes. However, the risk of reintervention at the index limb is higher after endovascular treatment. Randomized studies are now warranted to compare both techniques in terms of medical and financial aspects. Atherectomy followed by DCB of symptomatic DFA is safe and effective. In patients with comparable clinical and lesion characteristics, outcomes are comparable with surgery. However, the risk of reintervention at the index limb is higher after endovascular treatment. Therefore, whenever possible an additional outflow vessel revascularization should be performed by the time of the primary intervention. Randomized studies are warranted to compare endovascular techniques and open surgery also under economic aspects.

Drug-Coated Balloon Angioplasty for In-Stent Restenosis in the Vertebral Artery Ostium: Experiences From a Single Center.

Background and purpose: Stenting appears to be a safe treatment for vertebral artery ostial stenosis (VAOS) with low complication rates and positive long-term effects. However, in-stent restenosis (ISR) after stenting is common. Drug-coated balloons (DCBs) are an effective management strategy for ISR in patients with coronary or carotid disease. In this study, we investigated the feasibility, safety, and effectiveness of DCB-assisted angioplasty for the treatment of ISR after treatment of VAOS. Research Design: The study included patients in the Department of Neurology at Beijing Tsinghua Changgung Hospital who underwent DCB-assisted angioplasty for ISR after previously undergoing stenting for VAOS. We retrospectively analyzed the clinical and functional outcomes in these patients. Results: Fourteen patients were enrolled in the study between January 2018 and April 2022. Five of the patients were female, and the mean age was 69.4 ± 7.5 years. The technical success rate was 100% and the mean operation time was 57.1 ± 29.2 minutes. No perioperative complications were reported. There were no new cases of cerebral infarction or transient ischemic attacks in hospital or during 6 months of follow-up. There were only 2 reports of ISR in the vertebral artery ostium in the 6 months following DCB-assisted angioplasty. The median modified Rankin scale score was 0. Conclusion: DCB-assisted angioplasty may be feasible for treatment of ISR after stenting of the vertebral artery ostium. However, more research is needed to confirm our findings.

Long-term clinical outcomes of drug-coated balloon angioplasty for de novo coronary lesions in patients with diabetes mellitus.

We investigated whether drug-coated balloon (DCB) treatment is effective for all de novo cases of coronary artery disease (CAD) in patients with diabetes mellitus. Furthermore, we also investigated the relationship between the degree of diabetes mellitus and clinical outcomes after DCB treatment. In this study, we included 516 consecutive patients with de novo CAD who were treated with DCB. The patients were divided into the diabetic and non-diabetic groups. Patients with diabetes mellitus were further classified into non-insulin-treated diabetes mellitus (NITDM) and insulin-treated diabetes mellitus (ITDM). The primary endpoints were major adverse cardiovascular ischemic events (MACE) and clinically driven target lesion revascularization (CD-TLR). Within a mean clinical follow-up period of 2.5years, the incidence of MACE among patients with diabetes mellitus (22.1%) was almost twice that of non-diabetic patients (11.9%) with a relative risk of 1.86 (95% CI 1.24-2.79, p = 0.002). The 3-year CD-TLR occurred in 28 patients with diabetes mellitus (10.6%) and 13 non-diabetic patients (5.1%, p = 0.02). ITDM patients had a significantly higher rate of MACE compared with non-diabetic patients with a relative risk of 2.86 (95% CI 1.76-4.63, p = 0.0002). ITDM remained an independent predictor of 3-year MACE with an odd ratio of 1.96 (95% CI 1.00-3.83, p = 0.05). In patients undergoing DCB, the presence of DM was associated with a higher risk of MACE and CD-TLR. Particularly in DCB, treatment was still inadequately effective for ITDM patients.

Coronary plaque modification and impact on the microcirculation territory after drug-coated balloon angioplasty: the PLAMI study

Coronary plaque modification and impact on the microcirculation territory after drug-coated balloon angioplasty: the PLAMI study

TCT-435 Validation of Complex PCI Criteria in Drug-Coated Balloon Angioplasty

TCT-435 Validation of Complex PCI Criteria in Drug-Coated Balloon Angioplasty

Comparison of drug-coated balloon versus plain balloon angioplasty for autogenous hemodialysis access dysfunction: A prospective cohort study

Comparison of drug-coated balloon versus plain balloon angioplasty for autogenous hemodialysis access dysfunction: A prospective cohort study

TCT-693 Clinical Outcome of Between Low- and High-Dose Drug-Coated Balloon Angioplasty Performing Intraplaque Wiring for Femoropopliteal Artery Chronic Total Occlusion Lesions

TCT-693 Clinical Outcome of Between Low- and High-Dose Drug-Coated Balloon Angioplasty Performing Intraplaque Wiring for Femoropopliteal Artery Chronic Total Occlusion Lesions

TCT-453 Comparison of “Predicted” Versus “Calculated” Flow Ratio (μFR) Acquired With Single-Angiographic View to Guide Drug-Coated Balloon Angioplasty in Coronary De-Novo Lesions

TCT-453 Comparison of “Predicted” Versus “Calculated” Flow Ratio (μFR) Acquired With Single-Angiographic View to Guide Drug-Coated Balloon Angioplasty in Coronary De-Novo Lesions

Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting: TheMulticenter Randomized DCB-BIF Trial.

Side branch stenting is often required during provisional stenting, leading to suboptimal results. Drug-coated balloons (DCB) for the compromised side branch have emerged as an attractive strategy. However, the benefit of DCB for coronary bifurcations remains unclear. This study aimed to investigate whether DCB, compared with a noncompliant balloon (NCB), for the pinched side branch improves the outcomes of provisional stenting in patients with simple, true coronary bifurcations. In this multicenter, randomized controlled trial, patients with true coronary bifurcations who had side branch diameter stenosis of≥70% after main vessel stenting at 22 centers in China, Indonesia, Italy, and Korea were randomly assigned to either DCB or NCB intervention. The primary endpoint was major adverse cardiac events, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target-lesion revascularization at the 1-year follow-up. Between September 8, 2020, and June 2, 2023, 784 patients with true coronary bifurcation lesions undergoing main vessel stenting and having a severely compromised side branch were randomly assigned to the DCB (n=391) or NCB (n=393) group. One-year follow-up was completed in all patients. The primary endpoint occurred in 28 patients in the DCB group and 49 patients in the NCB group (Kaplan-Meier rate: 7.2% vs 12.5%; HR: 0.56; 95%CI: 0.35-0.88; P=0.013), driven by a reduction in myocardial infarction. There were no significant differences between groups in procedural success, crossover to a 2-stent approach, all-cause death, revascularization, or stent thrombosis. In patients with simple and true coronary bifurcation lesions undergoing provisional stenting, main vessel stenting with a DCB for the compromised side branch resulted in a lower 1-year rate of the composite outcome compared with an NCB intervention for the side branch. The high rates of periprocedural myocardial infarction, which occurred early and did not lead to revascularization, are of unclear clinical significance.

TCT-440 Angiography-Derived Radial Wall Strain Predicts Efficacy of Drug-Coated Balloon Angioplasty for De Novo Small Vessel Disease: Insights From the PEPCAD China SVD Study

TCT-440 Angiography-Derived Radial Wall Strain Predicts Efficacy of Drug-Coated Balloon Angioplasty for De Novo Small Vessel Disease: Insights From the PEPCAD China SVD Study

TCT-493 Drug-Coated Balloon Angioplasty vs Plain Balloon Angioplasty in Patients With Coronary In-Stent Restenosis: A Meta-Analysis of Randomized Controlled Trials

TCT-493 Drug-Coated Balloon Angioplasty vs Plain Balloon Angioplasty in Patients With Coronary In-Stent Restenosis: A Meta-Analysis of Randomized Controlled Trials

Effectiveness of Atherectomy and Drug-Coated Balloon Angioplasty in Femoropopliteal Disease: A Comprehensive Outcome Study.

Atherectomy has been reintroduced for debulking calcified atheroma to enhance the efficacy of drug-coated balloons (DCBs); however, its efficacy in severe calcification and related outcomes have not been fully evaluated. This study aimed to evaluate the outcomes of atherectomy and DCB angioplasty for treating femoropopliteal occlusive disease (FPOD). From 2014 to July 2022, 85 limbs in 76 patients with FPOD underwent atherectomy with DCB angioplasty. We evaluated the efficacy of this procedure using primary patency (PP) and clinically driven target lesion revascularization (CD-TLR)-free survival. PP was defined as the duration of uninterrupted patency without occlusion or a peak systolic velocity ratio more than 2.5 at the target lesion. Lesion calcification was evaluated according to Peripheral Arterial Calcium Scoring System, and Grade 4 was classified as severe. Seventy-one (84%) cases were male, and 56 limbs (66%) were treated for claudication. Rotational and directional atherectomies were performed in 62 (73%) and 23 limbs, respectively. The improvement in the median ankle-brachial index was 0.36 (interquartile range, 0.25-0.48). Median follow-up duration was 19.4 months. The overall PP and CD-TLR-free survival rates were 77% and 93% at 1 year and 64% and 83% at 2 years, respectively. On multivariable analysis, female sex (adjusted hazard ratio [aHR], 3.77; 95% confidence interval (CI), 1.30-10.87, P=0.014), dialysis (aHR, 4.35; 95% CI, 1.33-13.22, P=0.015), and severe calcification (aHR, 2.42; 95% CI, 1.07-5.46, P=0.033) were independent risk factors for poor PP. Dialysis (aHR, 11.07; 95% CI, 3.72-32.92, P<0.001) and severe calcification (aHR, 3.19; 95% CI, 1.15-8.84, P=0.026) were identified as independent risk factors for CD-TLR. Atherectomy with DCB angioplasty for FPOD did not work well in female patients, patients with lesions with severe calcification, and patients undergoing dialysis. Therefore, careful monitoring of these patients is crucial for patency loss and the requirement for revascularization. Additionally, for these patients requiring revascularization, surgical bypass may be appropriate for suitable candidates; whereas more proactive conservative management may be justified for claudicants.

Three-Year Safety and Efficacy of Endovascular Treatment of Common Femoral Artery in 150 PAD Patients.

Background: The gold standard treatment for peripheral arterial disease (PAD) of the common femoral artery (CFA) is open common femoral endarterectomy (CFAE). Interest in the less invasive endovascular treatment (EVT) is growing due to PAD patients' frequent co-morbidities. Aims: We aimed to evaluate three-year EVT outcomes in multimorbid PAD patients with severe calcified CFA lesions. Methods: Using the prospectively maintained "all-comers" Duesseldorf PTA Registry, we analysed the three-year outcomes of 150 patients with EVT of the CFA. Between January 2017 and October 2023, 66 patients received a rotational excisional atherectomy (REA) followed by a drug-coated balloon angioplasty (DCB), and 84 patients received a DCB alone. Results: All procedures involved the CFA, 49% additionally involved the proximal superficial femoral artery (SFA), and 10% of the lesions involved the profunda femoris artery (PFA). The procedural success rate was 97% and independent of PAD stage, with a higher level of stent implantation in the DCB group (58% vs. 39%, p < 0.05). The primary patency rate at one year was 83% for REA + DCB and 87% for DCB (p = 0.576), while secondary patency after three years was 97%. The MALE rate at three years was mainly driven by cdTLR (REA + DCB: (20%) vs. DCB: (14%), p = 0.377), while major amputations were low in both groups (REA + DCB: 3% vs. DCB: 1%). Overall, the major adverse cardiovascular events (MACEs) rate at three years was low (REA + DCB: (5%) vs. DCB: (11%), p = 0.170). Conclusions: The EVT of severely calcified CFA lesions is safe and effective, with high three-year patency rates and low rates of major adverse limb events (MALEs) and MACEs. This registry demonstrates that vessel preparation with REA minimizes the need for stenting.

Is intravascular ultrasound needed to optimize drug-coated balloon angioplasty results?

Is intravascular ultrasound needed to optimize drug-coated balloon angioplasty results?

Efficacy of a novel method: VaSodilator injection via the Over-the-wire lumen during drug-coated balloon dilatation to Prevent the slow-flow phenomenon in treatment of femoropopliteal lesions.

In drug-coated balloon (DCB) angioplasty for femoropopliteal lesions, there are adverse effects of drug embolization on downstream non-target organs following the slow-flow phenomenon. We devised a novel method, known as VaSodilator injection via the Over-the-wire lumen during DCB dilatation to Prevent the slow-flow phenomenon in treatment of femoropopliteal lesions (V.S.O.P.), and evaluated its efficacy and safety. This single-center, retrospective, observational study analyzed 196 femoropopliteal lesions treated with IN.PACT Admiral between April 2018 and July 2023. The IN.PACT Admiral is a DCB consisting of a 0.035-inch over-the-wire (OTW) lumen balloon coated with high-dose paclitaxel. Regarding the V.S.O.P. method, we injected vasodilators through the OTW lumen during DCB dilation of the lesions. The cohort was classified into two groups according to the use of the V.S.O.P. method (V.S.O.P. group: n = 53; non-V.S.O.P. group: n = 143). The V.S.O.P. group had lower rates of hemodialysis (21% vs. 43%, p = 0.01) and higher rates of critical limb-threatening ischemia (56% vs. 23%, p < 0.01) and severe calcification lesions (Peripheral Arterial Calcium Scoring Systems score 3/4) (53% vs. 34%, p = 0.01) than the non-V.S.O.P. group. The occurrence of the slow-flow phenomenon was significantly lower in the V.S.O.P. group than in the non-V.S.O.P. group. The V.S.O.P. method could be an effective method for preventing the slow-flow phenomenon after DCB angioplasty for femoropopliteal lesions.

The Midterm Outcomes of Endovascular Therapy for Femoropopliteal Lesions via Drug-Coated Balloon, Directional Atherectomy and Bare Metal Stent Angioplasty.

This study investigated the midterm primary patency of drug-coated balloons (DCBs), directional atherectomy plus balloon angioplasty (DA), and bare metal stent (BMS) angioplasty for the treatment of femoropopliteal lesions. This two-center retrospective cohort study included 105 patients (110 limbs) undergoing DCB, DA, and BMS angioplasty-32 patients (34 limbs), 31 patients (32 limbs), and 42 patients (44 limbs), respectively. The demographic, baseline, and procedure data were collected, and the complications and midterm outcomes (patency, amputation-free survival, and clinically driven target lesion revascularization rates) were analyzed. All three procedures achieved a 100% success rate. Significant improvements were noted in ankle brachial index, walking distance, and Rutherford classification at 30 days post-procedure (p < 0.001), with no differences or severe complications among the groups. The all-cause mortality rate during the follow-up period, was 5.5%, and amputation-free survival rates at 24 months were 97.0%, 90.6% and 90.9% in the DCB, DA, and BMS angioplasty groups, respectively. The primary patency rate for the DCB group (79.4%) exceeded those of the DA (56.2%) and BMS (52.2%) groups (p < 0.05), with no significant difference between the DA and BMS groups at 24 months. The secondary patency and clinically driven target lesion revascularization rates were similar among the three groups. A runoff number ≤1, Trans-Atlantic Intersociety Consensus (TASC) D, and severe calcification were found to be independent risk factors for primary patency. The DCB procedure demonstrated superior primary patency, compared to both BMS and DA procedures, in the treatment of femoropopliteal lesions.